key: cord-0998894-zexq6nw6
authors: Chew, Nicholas WS; Ow, Zachariah Gene Wing; Teo, Vanessa Xin Yi; Heng, Ryan Rui Yang; Ng, Cheng Han; Lee, Chi-Hang; Low, Adrian F.; Chan, Mark Yan-Yee; Yeo, Tiong-Cheng; Tan, Huay-Cheem; Loh, Poay-Huan
title: The Global Impact of the COVID-19 Pandemic on STEMI care: A Systematic Review and Meta-Analysis
date: 2021-04-20
journal: Can J Cardiol
DOI: 10.1016/j.cjca.2021.04.003
sha: 43ff6e81e4bc6af2183c56c48b669a53658072a7
doc_id: 998894
cord_uid: zexq6nw6

Background The coronavirus disease-2019 (COVID-19) pandemic has affected patients with ST-segment elevation myocardial infarction (STEMI) requiring primary percutaneous coronary intervention (PCI) worldwide. This review examines the global impact of COVID-19 pandemic on incidence of STEMI admissions, and relationship between the pandemic and door-to-balloon time (D2B), all-cause mortality and other secondary STEMI outcomes. Methods We performed a systematic review and meta-analysis to primarily compare D2B time and in-hospital mortality of STEMI patients who underwent primary PCI during and before the pandemic. Subgroup analyses were performed to investigate the influence of geographical region and income status of a country on STEMI care. An online database search included studies comparing the aforementioned outcomes between STEMI patients during and before the pandemic. Results In total, 32 articles were analyzed. Overall, 19,140 and 68,662 STEMI patients underwent primary PCI during and before the pandemic respectively. Significant delay in D2B was observed during the pandemic (WMD=8.10mins; CI:3.90-12.30mins; p=0.0002, I2=90%). In-hospital mortality was higher during the pandemic (OR=1.27; CI:1.09-1.49; p=0.002, I2=36%), however this varied with factors such as geographical location and income status of a country. Subgroup analysis found that low-middle income countries observed a higher rate of mortality during the pandemic (OR=1.52; CI:1.13-2.05; p=0.006), with a similar but insignificant trend seen among the high income countries (OR=1.17; CI:0.95-1.44; p=0.13). Conclusion The COVID-19 pandemic is associated with worse STEMI performance metrics and clinical outcome, particularly in the Eastern low-middle income status countries. Better strategies are needed to address these global trends in STEMI care during the pandemic.

This review compared door-to-balloon (D2B) time and in-hospital mortality of patients with ST-segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention (PCI) during and before the pandemic. Significant delay in D2B was observed during the pandemic. In-hospital mortality was higher during the pandemic; this varied with geographical location and country's income status. Low-middle income countries observed a higher mortality rate. The pandemic is associated with worse STEMI performance metrics and clinical outcome.

We performed a systematic review and meta-analysis to primarily compare D2B time and in-hospital mortality of STEMI patients who underwent primary PCI during and before the pandemic. Subgroup analyses were performed to investigate the influence of geographical region and income status of a country on STEMI care. An online database search included studies comparing the aforementioned outcomes between STEMI patients during and before the pandemic.

In total, 32 articles were analyzed. Overall, 19 ,140 and 68,662 STEMI patients underwent primary PCI during and before the pandemic respectively. Significant delay in D2B was observed during the pandemic (WMD=8.10mins; CI:3.90-12.30mins; p=0.0002, I 2 =90%). In-hospital mortality was higher during the pandemic (OR=1.27; CI:1.09-1. 49; p=0.002, I 2 =36%), however this varied with factors such as geographical location and income status of a country. Subgroup analysis found that low-middle income countries observed a higher rate of mortality during the pandemic (OR=1.52; CI:1.13-2.05; p=0.006), with a similar but insignificant trend seen among the high income countries (OR=1.17; CI:0.95-1.44; p=0. 13) .

The coronavirus disease-2019 (COVID- 19) pandemic has overwhelmed all levels of medical services in many countries with a substantial strain on healthcare personnel and medical resources 1 . An integrated network of emergency medical services (EMS), emergency departments (ED), referring hospitals and PCI-capable hospitals is vital in STEMI care to ensure timely reperfusion for patients with ST-segment elevation myocardial infarction (STEMI), especially during the pandemic 2 . While primary PCI is the standard reperfusion strategy during the pandemic as recommended by major guidelines 3 , performing such highrisk procedure on patients with confirmed or unknown COVID-19 status will put healthcare workers and other patients at risk of transmission. On the other hand, strict infection control measures may potentially delay treatment 4 . Hence, treatment strategies for STEMI patients have differed across countries [5] [6] [7] [8] [9] [10] in an attempt to strike a balance between optimal STEMI care and safety of the community 2 . The global impact of such strategies on STEMI outcome is still unknown.

Multiple observational studies have reported varying degree of reduction in STEMI presentations and delay in PCI treatment across the globe [11] [12] [13] [14] [15] . However, most of these studies were small, based on the experience of a single center or involved registry data from the Western developed world. Thus, we sought to perform a systematic review and meta-analysis on such a heterogeneous group of studies in order to examine: the incidence of STEMI admissions during the COVID-19 pandemic compared to before the pandemic, the relationship between the pandemic and door-to-balloon time (D2B), mortality and other important secondary STEMI outcomes, as well as the effect of geographical and economic differences on these outcomes.

The Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines were used in the synthesis of this review 16 Additionally, references from included studies and pertinent review articles were searched to identify other potential studies meeting the selection criteria. The search was limited to articles written in the English language. An example of the search strategy can be found within the Supplementary Appendix S1.

Article sieving was performed by two authors (VXYT and RRYH) working independently with any discrepancies being resolved by achieving a consensus with a third and senior author (NWSC). Inter-rater agreement was quantified through the use of Cohen's Kappa statistic coefficient, k, with standard agreement definition being used to quantify degrees of agreement 17 . This review primarily focused on comparing the D2B and mortality rates of STEMI patients before and during the pandemic. The inclusion criteria were that of (1) cohort studies comparing the outcome of patients treated during and before the COVID-19 pandemic, (2) studies involving patients presenting with STEMI, and (3) studies wherein all patients underwent coronary angiography with the intent for PCI as the treatment strategy of choice. Studies that reported on either D2B or mortality were included. However, studies were excluded when they included patients with non-specific diagnosis at presentation, patients with non-STEMI, or if they failed to make a comparison between patients treated during and before the COVID-19 pandemic.

Data from included studies was extracted by the same independent pair of authors (VXYT and RRYH) using a standardized protocol and reporting form. Disagreements were resolved by obtaining the consensus with a senior author. The following information was extracted: study characteristics (study name, authors, publication year, country of origin, sample size, and the pandemic and pre-pandemic periods as defined by the individual studies), study sample characteristics (mean age, sex and major comorbidities), and primary and secondary outcomes as detailed below.

The primary outcome for medical service efficiency was D2B, while the primary treatment outcome was all-cause mortality. D2B was defined as the length of time during which the patient with STEMI arrived at the hospital to either needle entry, balloon inflation, or other device deployment 18 . If a study reported multiple time points, the time from hospital arrival to balloon inflation was used for our analysis. A summary of the definitions of D2B by individual studies can be found within Supplementary Table S1 .

Secondary outcomes included onset-to-door time (O2D), left ventricular ejection fraction (LVEF), cardiogenic shock, procedural success, length of hospital and intensive care unit (ICU) stay, and major adverse cardiac events (MACE). MACE was defined as a combination of all-cause mortality, repeat revascularization, stroke, heart failure, non-fatal re-infarction, stent thrombosis or major bleeding 19 . O2D time was defined as the time between the onset of symptoms and arrival at the ED of a PCI-capable hospital [20] [21] [22] [23] [24] . Study characteristics, patient demographics, procedural outcomes (D2B, post-PCI thrombolysis in myocardial infarction

[TIMI] flow grade), and complications were extracted from included studies. When the mean and standard deviation were not available, estimation of mean and standard deviation was performed with the methods described by Wan et al 25 using the study sample size, median, range and/or interquartile range.

Pairwise meta-analysis was performed to synthesize observational data for binary and continuous outcomes. Odds Ratios (OR) were used to compare binary outcome data, and Weighted Mean Differences (WMD) were used to compare continuous outcome data. In the analysis of OR and WMD, the Mantel-Haenszel and inverse variance models were used to pool the results respectively. Heterogeneity scores were measured by I 2 statistic and Cochran's Q test, with 40% or p<0.10 respectively indicative of substantial heterogeneity 26 .

Random effects were used in all analysis regardless of heterogeneity. All analyses were Figure S1 ). When there were sufficient studies reporting a given outcome (n>10), publication bias was assessed through the use of Egger's regression and Harbord's test for continuous and binary outcomes respectively.

There were methodological challenges in studying the effect of pandemic on the prognosis of STEMI patients that conventional risk of bias tools, such as ROBINS-I, would have been suboptimal in the evaluation of COVID-19 era studies due to the presence of collider bias 28 .

A systematic review performed by Iwakami et al described the suitability of the Quality In Prognosis Studies (QUIPS) 29 in the bias assessment of included studies comparing the prognosis of retrospectively replicated cohorts 30 . The QUIPS tool evaluates the risk of bias of studies utilizing six domains, namely, study participation, study attrition, prognostic factor measurement, outcome measurement, study confounding and statistical analysis. Quality assessment of included articles was performed using the Newcastle-Ottawa Scale (NOS), which grades each article on the cohort selection, as well as the adequacy of outcomes measured 31 . Two authors (RRYH and VXYT) performed concurrent independent bias evaluation of the studies.

A flow diagram of the literature search and related screening process is shown in Figure 1 Table S2 ). Several studies reported the proportion of patients presenting with out-of-hospital cardiac arrests (OHCA) and cardiogenic shock on arrival. In all the three studies reporting OHCA, the proportion of patients presented with OHCA was observed to be greater during compared to before the pandemic 23, 43, 60 . Seven studies reported the proportion of patients presented with cardiogenic shock, of which five studies showed greater proportion of patients presented with cardiogenic shock during compared to before the pandemic 20, 43, 44, 49, 60 . A summary of the results can be found within the supplementary material (Supplementary Table S3 ).

Nineteen studies reported D2B at their respective institutions. D2B was found to be significantly longer during, as compared to, before the pandemic (n=49,505; WMD = 8.10 mins; 95% CI: 3.90 to 12.30 mins; p=0.0002). As study heterogeneity of the overall D2B time comparison was considerable (I 2 =90%), subgroup analyses were performed to further investigate heterogeneity. D2B time was observed to be significantly longer during the pandemic in both the Western (n=47,087; WMD = 4.75 mins; 95% CI: 0. 68 countries; without any overall difference between both subgroups (p=0.12) (Figure 2) . Figure 3 ). Mortality rates were 4.90% (636/12,969) and 4.07% (737/18,097) during and prior to the pandemic respectively for centers based in the Eastern countries, and 6.58%

(387/5,885) and 4.82% (2,333/48,416) during and prior to the pandemic respectively for centers based in the Western countries. There was no significant difference in mortality rates between the two geographical regions (p=0.34).

Additional subgroup analysis comparing high income to low-middle income countries showed a significantly increased rate of mortality among the low-middle income countries during, as compared to, prior to the pandemic (n=30,098; OR=1.52; 95% CI: 1.13 to 2.05; p=0.006). Conversely there was observable increase in mortality among the high income countries intra-pandemically compared to the pre-pandemic period, although this did not reach statistical significance (n=55,269; OR=1.17; 95% CI: 0.95 to 1.44; p=0.13, Figure 4 ).

There was no significant difference in mortality rates between the high and low-middle income countries (p=0.16).

On further analysis of the subgroup of Eastern countries, Eastern low-middle income countries in particular observed a significantly higher mortality rate during the COVID-19 pandemic (n=30,098; OR=1.52; 95% CI: 1.13 to 2.05; p=0.006). However, the Eastern high income countries did not experience significantly different mortality rates between the time periods during and prior to the pandemic (n=968; OR=1.01; 95% CI: 0.55 to 1.87; p=0.98).

The differences in mortality by the income status of the Eastern countries was not significant (p=0.24).

Nine studies reported the delay in O2D. The COVID-19 pandemic was associated with patients having a significantly longer O2D time, as compared to patients presenting prior to the pandemic (n=37,331; WMD=38.22mins; 95% CI: 12.67 to 63.77 mins; p=0.003).

Considering the eight studies that reported LVEF of the patients upon discharge, patients underwent PCI during the pandemic had worse LVEF as compared to those treated before the 

There was an increased risk of MACE during the pandemic, as compared to the pre-pandemic period (n=65,436; OR=1.54; 95% CI: 1.18 to 2.00; p=0.001).

This meta-analysis is the first to demonstrate that the delays caused by COVID-19 pandemic in STEMI care could be associated with an increased mortality rate, especially among the low-middle income countries. There was significant increase in D2B time and mortality rate during, as compared to, before the pandemic. The increase in D2B time was observed regardless of the geographical location or country income status. However, after adjusting for relevant variables, mortality rate during the pandemic was significantly increased only among the Eastern low-middle income countries.

During the pandemic, there was a global reduction in STEMI admissions as compared to before the pandemic 61 . Of the 32 included studies, 21 made a time-matched comparison of the number of STEMI admissions between the study periods. All 21 studies reported decreased STEMI admissions to the respective institutes during compared to before the pandemic (Table 1) . Among studies that reported clinical presentations, there was a higher proportion of patients with more severe clinical presentations (cardiogenic shock and OHCA) during compared to before the pandemic 20, 24, 32, 35, 43, 44, 49, 60 . Patients admitted during the pandemic had less favorable procedural outcomes with higher proportion of them had post-PCI TIMI <3 grading, and worse clinical outcomes as evident by higher incidences of MACE, lower LVEF on discharge and longer ICU stay compared to those admitted before the pandemic.

The pro-thrombotic milieu of the COVID-19 virus infection, with the potential increased tendency of plaque rupture has led to an anticipated increase in patients presenting with acute coronary syndromes [62] [63] [64] . Paradoxically, there was a global reduction of STEMI-related hospitalizations in the usually high-volume centers irrespective of geographically location 15, [65] [66] [67] . It has been postulated that this reduction could be attributed to fewer patients seeking help for STEMI-related symptoms due to fear of COVID-19 exposure or reduced access to medical services as a result of the overwhelmed health services. Such adverse health-seeking behavior was not limited to geographical regions with higher COVID-19 burden or death toll. De Luca and colleagues found significant heterogeneity in primary PCI volume across different European centers which was unrelated to the number of COVID-19 cases or COVID-19-related deaths 60 . As a result, increased mortality and morbidity due to prolonged total ischemic time and associated adverse consequences has been observed in multiple studies 20, 21, 24, 32, 33, 37, 45, 54, 58, 60 .

Interventions still advocate PCI as the main reperfusion strategy for STEMI patients during the pandemic with the same general D2B targets 68 Moreover, the significant delay in O2D observed during the pandemic is also alarming.

Several studies postulated that the reasons for delay in O2D were related to the fear of COVID-19 exposure in hospitals, ill-informed altruistic behavior not to overburden the hospital system, or social distancing measures [11] [12] [13] [14] [15] 70 . Additionally, it remains plausible that the more severe disease state at presentation among patients observed during the pandemic could also partly be related to delayed presentation and/or treatment, potentially translating to poorer long-term outcomes. This is consistent with our findings of the universally higher incidence of MACE and worse LV systolic dysfunction.

The advent of such barriers to timely reperfusion could be a plausible explanation for the increase in in-hospital mortality rates, with delayed O2D and D2B time potentially resulting in the failure to meet the limited window of time available for reperfusion to be effective in reversing the pathophysiology of ischemic cardiomyocyte death. Previous observational studies have suggested that small incremental improvements in D2B did not affect in-hospital mortality 71 . During the pandemic, there was, on average, an 8 minute delay in the D2B time.

Apart from the prolonged total ischemic time contributed by increased O2D (contributed by a complex interplay of patient and EMS-related delays), other pandemic-specific factors might contribute to the increased in-hospital mortality rates. It is intuitive to speculate that these pandemic-specific factors include the more severe clinical presentations, associated effects of social distancing such as more sedentary lifestyle, avoidance of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers use due to the initial alarming concern that these agents might increase susceptibility to COVID-19 infection 57 , and the overwhelmed support services in STEMI care such as respiratory therapy, and allied healthcare services including cardiac rehabilitation. As the pandemic continues to evolve, and with the increasing availability of the COVID-19 vaccine 72, 73 , only time will tell the true long-term impact of the pandemic on cardiovascular diseases and economic burden on healthcare system. For now, strategies to address healthcare system delays will help to reduce the total ischemic time 65 . Experience in the pandemic should serve as an important lesson to all levels of the healthcare system such that infection control measures might be more organized in dealing with future pandemics, and at the same time maintain the efficiency of time-sensitive acute medical services such as primary PCI and STEMI care.

The findings of our study are in stark contrast to a recent review which only included studies published before August 2020 and found no differences in short-term mortality before and during the pandemic among patients undergoing primary PCI for STEMI 74 . Global response to the pandemic is rapidly changing, and potentially diverging in terms of the pace at which certain countries mount the learning curve of adapting to the pandemic. As such, whilst early studies may have shown a global homogeneity in keeping intra-pandemic mortality rates comparable to that of pre-pandemic level, our latest cumulative evidence suggests a potential increase in overall short-term mortality rates among the Eastern countries and countries of lower income status during the pandemic. Through serial subgroup analyses adjusted for geographical location, income status, and subsequently both these variables, we observed that Eastern countries with a low-middle income status faced the highest increased rate of mortality during the COVID-19 pandemic. Conversely, the increase in mortality rates between the two study periods among the Western or high income countries was not statistically significant. This raises immediate concern on the challenges faced by the lowmiddle income countries during the pandemic and may suggest that countries lacking advanced infrastructure to surmount the barriers to timely reperfusion are unable to cope with the effects of COVID-19 pandemic on STEMI care.

This meta-analysis on the global impact of the COVID-19 pandemic on STEMI care raises relevant and immediate questions on strategies for subsequent rises in infection rates or, in a broader context, on future outbreaks. Recent evidence suggests a rebound increase in STEMI admissions reverting back to the usual 2019 levels a few months into the pandemic 23, 75 . These factors may exacerbate the strain on healthcare system with a longer-lasting impact both prognostically and economically. With the evidence from this study suggesting that the strain on healthcare system mainly affecting countries of low-middle income, a strong call to action can be made to greater optimize the pace at which such countries mount the response curve of adapting to the barriers to achieving timely reperfusion for STEMI patients. In general, all acute medical services especially the time-sensitive ones are likely to be adversely affected in one way or another. Lessons from previous and current outbreaks must be learned so that the world communities would be better prepared as COVID-19 pandemic continues to escalate and also for future outbreaks.

Although the findings are relevant to the COVID-19 pandemic, our study has several limitations. Firstly, although the differences in outcome between the two study periods were statistically significant, they should be interpreted with caution as the reporting of outcomes from different studies might vary. Furthermore, some subgroup analyses included relatively small sample size that might be underpowered to detect any clinically meaningful differences. Secondly, given the clinical context, all studies included in this analysis were retrospective studies. Moreover, D2B definitions may vary among the studies but they are considered clinically and prognostically relevant to the respective health systems. In addition, measures were taken to standardize the definition of D2B for this analysis by using the time from hospital arrival to balloon inflation if multiple time points were reported. In addition, our global estimates may be subjected to publication bias as studies included were limited to those published in English, and only certain healthcare organization had the capability to collect and publish data. Finally, only short-term outcomes are available at the current phase of COVID-19 pandemic. Longer term studies are vitally important especially that current data indicate poorer short-term outcomes among STEMI patients undergoing primary PCI, which in turn, could adversely impact the long-term outcomes of these patients. Interventions to mitigate delays and improve STEMI care efficiency during the pandemic should be evaluated.

The COVID-19 pandemic is associated with worse STEMI performance metrics and clinical outcomes worldwide with worse clinical status at presentation, D2B delay irrespective of geographic location or income status of a country, as well as less favorable post-PCI outcomes despite a reduction in STEMI admissions. Mortality rates, whilst unaffected in high income countries, significantly increased during the COVID-19 pandemic in low-middle income countries. Better strategies are needed to address these global trends in STEMI care especially among the communities at risk. 

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Funding: No sources of funding were present in this study Disclosures: All the authors have no conflict of interest to declare.